Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

Show Filters

OrthAlign Plus Unit
Orthalign, Inc.
403001-05
In Commercial Distribution

  • 00851977007918 ()
  • 00851977007901 ()
403001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
OrthAlign Plus Unit - No DAA
Orthalign, Inc.
403001-03
In Commercial Distribution

  • 00851977007383 ()
  • 00851977007376 ()
403001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
SpydrBlade Flex is indicated for use in the cutting (incision, dissection, avulsion) of soft tissue using radiofrequency current and the coagulation (hemostasis, cauterization, ablation, arrest of bleeding) of soft tissue using microwave energy in the gastrointestinal tract as required or encountered in endoscopic procedures.
CREO MEDICAL LIMITED
PRD-RG1-001
In Commercial Distribution

  • 05060359560438 ()
  • 05060359560445 ()

  • Length: 1.8 Meter
  • Outer Diameter: 2.7 Millimeter
PRD-RG1-001

  • Endoscopic electrosurgical/microwave submucosal lift/resection instrument
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-31-5
In Commercial Distribution

  • 56971227400395 ()
  • 36971227400391 ()
  • 16971227400380 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-30-5
In Commercial Distribution

  • 36971227400384 ()
  • 16971227400380 ()
  • 56971227400388 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-30-8
In Commercial Distribution

  • 56971227400371 ()
  • 36971227400377 ()
  • 16971227400373 ()


  • Autoinjector needle
The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer. The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release. The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.
Vitrolife A/S
16455
In Commercial Distribution

  • 05712714000041 ()
  • 15712714000048 ()
16455

  • Assisted reproduction procedure dish
Guidewire and Guidewire Manipulation Device
BOSTON SCIENTIFIC CORPORATION
H802228240020
In Commercial Distribution

  • 08714729195566 ()
  • 08714729185871 ()

  • 0.009 in Diameter
  • 330 cm Length
H802228240020

  • Cardiac/peripheral vascular guidewire, single-use
Guidewire and Guidewire Manipulation Device
BOSTON SCIENTIFIC CORPORATION
H802232390010
In Commercial Distribution

  • 08714729195573 ()
  • 08714729144168 ()

  • 330 cm Length
  • 0.009 in Diameter
H802232390010

  • Cardiac/peripheral vascular guidewire, single-use
Guidewire Manipulation Device
BOSTON SCIENTIFIC CORPORATION
H802221960030
In Commercial Distribution

  • 08714729195535 ()
  • 08714729154785 ()
H802221960030

  • Cardiac/peripheral vascular guidewire, single-use
< 1 ... 122 123 124 125 126 127 >